Applied Technical Services
★★★★★
3.5
/ 5
•
11 reviews
FDA 510(k) Regulatory Consulting Services
Applied Technical Services is a consulting firm specializing in FDA 510(k) regulatory consulting. With 12 years of experience, they provide comprehensive support for medical device companies seeking 510(k) clearance across all device classes (I, II, and III). Their services include 510(k) consulting and in-house testing lab capabilities.
About
Applied Technical Services is a consulting firm specializing in FDA 510(k) regulatory consulting. With 12 years of experience, they provide comprehensive support for medical device companies seeking 510(k) clearance across all device classes (I, II, and III). Their services include 510(k) consulting and in-house testing lab capabilities.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Applied Technical Services
- **Years of experience:** 12
- **510(k)s submitted (self-reported):** 10
- **Regions served:** US
- **Client types:** large_medtech, startup, sme
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Applied Technical Services (ATS) offers a compelling value proposition by combining 510(k) regulatory consulting with in-house testing lab capabilities. With 12 years of experience, ATS provides comprehensive support for medical device companies seeking 510(k) clearance across all device classes (I, II, and III). Their fixed-project pricing structure offers predictability for clients, and their focus on traditional 510(k) submissions suggests a streamlined and efficient approach to this common regulatory pathway. The integration of testing services and consulting provides a single point of contact for both regulatory strategy and necessary testing, potentially accelerating the clearance process.
- **Unique value:** ATS uniquely combines 510(k) regulatory consulting with in-house testing lab services, offering a streamlined, integrated solution that can accelerate the 510(k) clearance process and reduce the need to manage multiple vendors.
- **Ideal projects:** The ideal project for ATS involves medical device companies, particularly those developing Class I, II, or III devices requiring a traditional 510(k) submission. Companies that would benefit most are those seeking a streamlined approach that integrates testing and regulatory consulting. Given their expertise in 510(k) submissions, ATS is well-suited for projects where the regulatory pathway is relatively well-defined and the client needs assistance with documentation, testing coordination, and submission preparation. While they work with all device classes, their expertise likely lies in devices that require standard testing procedures readily available through their lab network.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:11:22 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** other, regulatory strategy, risk management
- **Regulatory pathways:** 510k
- **Type:** firm
- **Company:** Applied Technical Services
- **Years of experience:** 12
- **510(k)s submitted (self-reported):** 10
- **Regions served:** US
- **Client types:** large_medtech, startup, sme
- **Location:** United States
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** Applied Technical Services (ATS) offers a compelling value proposition by combining 510(k) regulatory consulting with in-house testing lab capabilities. With 12 years of experience, ATS provides comprehensive support for medical device companies seeking 510(k) clearance across all device classes (I, II, and III). Their fixed-project pricing structure offers predictability for clients, and their focus on traditional 510(k) submissions suggests a streamlined and efficient approach to this common regulatory pathway. The integration of testing services and consulting provides a single point of contact for both regulatory strategy and necessary testing, potentially accelerating the clearance process.
- **Unique value:** ATS uniquely combines 510(k) regulatory consulting with in-house testing lab services, offering a streamlined, integrated solution that can accelerate the 510(k) clearance process and reduce the need to manage multiple vendors.
- **Ideal projects:** The ideal project for ATS involves medical device companies, particularly those developing Class I, II, or III devices requiring a traditional 510(k) submission. Companies that would benefit most are those seeking a streamlined approach that integrates testing and regulatory consulting. Given their expertise in 510(k) submissions, ATS is well-suited for projects where the regulatory pathway is relatively well-defined and the client needs assistance with documentation, testing coordination, and submission preparation. While they work with all device classes, their expertise likely lies in devices that require standard testing procedures readily available through their lab network.
- **Confidence score:** 70/100
- **Last analyzed:** Sun Dec 14 2025 01:11:22 GMT-0500 (Eastern Standard Time)
### **Qualifications & scope**
- **Submission types:** 510k-traditional
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** other, regulatory strategy, risk management
- **Regulatory pathways:** 510k
Key Highlights
- Applied Technical Services (ATS) offers a compelling value proposition by combining 510(k) regulatory consulting with in-house testing lab capabilities. With 12 years of experience, ATS provides comprehensive support for medical device companies seeking 510(k) clearance across all device classes (I, II, and III). Their fixed-project pricing structure offers predictability for clients, and their focus on traditional 510(k) submissions suggests a streamlined and efficient approach to this common r
- ATS uniquely combines 510(k) regulatory consulting with in-house testing lab services, offering a streamlined, integrated solution that can accelerate the 510(k) clearance process and reduce the need to manage multiple vendors.
Certifications & Trust Signals
- 12 years experience
- 10 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- The ideal project for ATS involves medical device companies, particularly those developing Class I, II, or III devices requiring a traditional 510(k) submission. Companies that would benefit most are those seeking a streamlined approach that integrates testing and regulatory consulting. Given their expertise in 510(k) submissions, ATS is well-suited for projects where the regulatory pathway is rel
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring
Pathways Supported:
Traditional 510(k)
Device Types Supported:
Medical device
Years Experience:
12
Num510k Submitted:
10
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Engagement Models:
fixed_fee
Accepting New Clients:
No
